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Clinical and analytical tests will be performed based on risk assessment and system specifications to verify that the performance of the investigational device is in accordance with its specifications.
Comparison and precision studies will be conducted in up to 5 clinical sites in Israel and the US, and include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hematology Analyzer - OLO | The investigational device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples. |
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| Hematology Analyzer - Predicate | The predicate device is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical and reference laboratories. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hematology Analyzer - OLO | Device | Complete blood counts from OLO will be determined from analysis of whole blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of CBC parameters provided by the OLO device | Reproducibility studies will be conducted using 3 levels of commercial control materials (low, normal and high) to measure all CBC reported parameters. Control material will be run on two instruments at each site. Standard deviation (SD) and coefficient of variation (CV) will be calculated for each measurand for: (1) Between lots/sites; (2) Between instruments; (3) Between days; (4)Between operators/runs; (5) within-run and (6) total variability | 3 months |
| Repeatability of CBC parameters provided by the OLO device | Performance of the OLO device will be measured through repeatability of 20 replicates for 11 residual samples on each site. Samples collected for this study will include 4 within lab reference range, 3 around lower medical decision levels for HGB, PLT and WBC, and 4 around the upper range for RBC, HGB, WBC and PLT to cover all pathological levels and medical decision points. Standard deviation (SD) and coefficient of variation (CV) will be computed for each measurand per sample by site. | 3 months |
| Sample Matrix Comparison | Paird capillary and venous whole blood samples will be collected. The samples will be analyzed in duplicate on the Sight OLO device. Analysis will include Passing-Bablok Regression analysis per parameter (Bland Altman plots, slope, intercept, with 95% confidence intervals, correlation coefficient, and % bias), between: The average of venous whole blood samples scans and average of capillary whole blood sample scans from the same individual on the Sight OLO device | 3 months |
| Method Comparison | Evaluate the performance of the OLO device in comparison to values achieved with the predicate. Analysis will include Regression parameters (slope, intercept with 95% CI) between measurement of Sight OLO and measurement on predicate (Correlation coefficient, Bland Altman plots and overall % bias between predicate and Sight OLO device including % bias at medical decision points). |
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Inclusion Criteria:
For Residual Samples:
For Prospectively collected samples:
Exclusion Criteria:
Exclusion criteria post blood draw and pre sample scan - For whole blood samples:
Exclusion criteria post sample scan:
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Adult and pediatric patients with normal (healthy) or abnormal blood counts (known clinical condition)
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Eldad Hod, Dr | Colombia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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| Hematology Analyzer - Predicate | Device | Complete blood counts from Predicate will be determined from analysis of whole blood samples |
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| 3 months |
| Reference Interval Range | Establish adult venous and fingerprick reference intervals for the OLO device. The non-parametric method will be used to calculate the lower and upper limits of the reference range. | 3 months |